The United States Food and Drug Administration (USFDA) has granted final approval to Zydus Lifesciences Limited (including its subsidiaries / affiliates, hereafter referred to as “Zydus”) for Apixaban Tablets, 2.5 mg and 5 mg (USRLD: Eliquis® Tablets).
Apixaban inhibits the activity of certain clotting factors in the blood. It is used to reduce the risk of stroke or blood clot in people who have atrial fibrillation, a heart rhythm disorder. It is also used to lower the risk of blood clot formation in the legs and lungs of people who have recently had hip or knee replacement surgery. It is also used to treat blood clots in the veins of the legs or lungs and to lower the risk of them recurring. The medication will be produced at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).
In the United States, Apixaban Tablets, 2.5 mg and 5 mg had annual sales of USD 18,876 million (IQVIA MAT Dec. 2022). Since the beginning of the filing process in FY 2003-04, the group has received 347 approvals and has filed over 440* ANDAs.